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Follow Ups of Parents With Infants With Cleft Lip and Palate

2021年9月22日 更新者：Kim Alexander Tønseth、Oslo University Hospital
In Norway, 100-120 children are born with CLP (1.9 per 1,000 live births) each year. Parents of infants with CLP need information and support, especially with feeding immediately after birth. These needs are often not met. The purpose of this study is to investigate the effect of systematic follow ups of parents with infants with CLP performed by a special trained nurse. Parental information needs, parental coping and stress and infant growth and feeding will be explored and compared to a control group receiving standard care. 26 parents (mothers and fathers) or more shall be included in each group according to specific criteria. The control should be examined first. Both groups will answer questionnaires 3 times during the child's first year.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

145

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 挪威
      • Oslo、挪威
        • Oslo university hospital; Rikshospitalet

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Parents of infants with cleft lip and palate (CLP); cleft lip, cleft palate or cleft lip and palate
  • Birthplace in south-east region of Norway
  • Scandinavian speaking parents

Exclusion Criteria:

  • Parents of infants with CLP who are referred to the hospital after the first measure point
  • Birthplace outside south-east region of Norway
  • Non-scandinavian speaking parents

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：Arm A

Standard care consists of:

  • a phone call from a CLP-nurse after the referral from the local birth hospital has been received
  • telephone service at parents request and at the staffs availability
  • invitation to a one-day-information course before surgery
有源比较器：Arm B

Systematic follow up by a special trained nurse consists of:

  • telephone contact with the parents shortly after birth
  • visit at the maternity ward within 36 hours after the referral has been received
  • telephone follow ups at specific times and at parents request
  • guidance and support in feeding and treatment
  • written information
  • cooperation with the staff at the maternity unit and the health centre
  • follow up in accordance with a check-list and log
  • invitation to a one-day-information course before surgery
其他：Cleft lip and palate
Comparison between Arm A who will receive standard care and Arm B who will receive systematic follow up performed by a special trained nurse will be performed.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
大体时间：1 month post partum
Both groups
1 month post partum
Parental coping as measured by Post-Discharge Coping Difficulty Scale (PDCDS)
大体时间：1 month post partum
Both Groups
1 month post partum
Quality of discharge teaching as measured by Quality of Discharge Teaching Scale (QDTS)-Parent form
大体时间：1 month post partum
Both groups
1 month post partum
Infant growth as measured by "Demographic data Questionnaire" and "Child health card"
大体时间：1 month post partum
Both groups
1 month post partum
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
大体时间：1 month post partum
Both groups
1 month post partum
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
大体时间：6 months post partum
Both groups
6 months post partum
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
大体时间：6 months post partum
Both groups
6 months post partum
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
大体时间：13 months post partum
Both groups
13 months post partum
Infant growth as measured by "Child health card"
大体时间：13 months post partum
Both groups
13 months post partum
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
大体时间：13 months post partum
Both groups
13 months post partum
Parental views on the follow up as measured by "Response on the follow up" (study specific questionaire)
大体时间：6 months post partum
Both groups
6 months post partum

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Oslo University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年4月1日

初级完成 (实际的)

2019年1月1日

研究完成 (实际的)

2019年1月1日

研究注册日期

首次提交

2015年2月27日

首先提交符合 QC 标准的

2015年4月8日

首次发布 (估计)

2015年4月14日

研究记录更新

最后更新发布 (实际的)

2021年9月23日

上次提交的符合 QC 标准的更新

2021年9月22日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2014/17828

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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